A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

Inclusion Criteria:

* Prior trial of total androgen blockade
* Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide).
* Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan
* ECOG ≤ 2
* Age ≥ 18 years
* Serum testosterone of ≤ 50 mg/dl
* PSA ≥ 2.0 ng/ml
* White blood cell count ≥ 3000/mm3
* Platelets ≥ 100,000/mm3
* Serum creatinine ≤ 1.5 x upper limits of normal
* Bilirubin ≤ 1.5 x upper limits of normal
* Alanine transaminase ≤ 1.25 x upper limits of normal
* Estimated life expectancy of at least 12 months
* Able and willing to sign informed consent

Exclusion Criteria:

* Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur)
* Known allergy to GnRH agonists or antagonists
* Previous treatment with Degarelix
* Major surgery within 4 weeks of registration
* Grade ≥ 3 peripheral neuropathy
* Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome
* Acute deep vein thrombosis or pulmonary embolism
* Taking anti-arrhythmia medication
* Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years.
* Prior orchiectomy for prostate cancer
* PSA \> 100 ng/mL